Caduet

OVERDOSE

There is no information on overdosage with CADUET in
humans.

Amlodipine

Overdosage might be expected to cause excessive
peripheral vasodilation with marked hypotension and possibly a reflex tachycardia.
In humans, experience with intentional overdosage of amlodipine is limited.

Single oral doses of amlodipine maleate equivalent to 40
mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively,
caused deaths. Single oral amlodipine maleate doses equivalent to 4 or more mg
amlodipine/kg or higher in dogs (11 or more times the maximum recommended human
dose on a mg/m² basis) caused a marked peripheral vasodilation and
hypotension.

If overdose should occur with amlodipine, initiate active
cardiac and respiratory monitoring. Perform frequent blood pressure
measurements. Should hypotension occur,provide cardiovascular support including
elevation of the extremities and administration of fluids. If hypotension
remains unresponsive to these conservative measures, consider administration of
vasopressors (such as phenylephrine) with specific attention to circulating
volume and urine output. As amlodipine is highly protein bound, hemodialysis is
not likely to be of benefit.

Atorvastatin

There is no specific treatment for atorvastatin
overdosage. In the event of an overdose, the patient should be treated
symptomatically, and supportive measures instituted as required. Because of
extensive drug binding to plasma proteins, hemodialysis is not expected to
significantly enhance atorvastatin clearance.

Pregnancy

Atorvastatin is contraindicated in women who are pregnant
or may become pregnant. Atorvastatin may cause fetal harm when administered to
a pregnant woman. Serum cholesterol and triglycerides increase during normal
pregnancy, and cholesterol or cholesterol derivatives are essential for fetal
development. Atherosclerosis is a chronic process and discontinuation of
lipid-lowering drugs during pregnancy should have little impact on the outcome
of long-term therapy of primary hypercholesterolemia.

There are no adequate and well-controlled studies of
atorvastatin use during pregnancy; however, in rare reports congenital
anomalies were observed following intrauterine exposure to statins. In rat and
rabbit animal reproduction studies, atorvastatin revealed no evidence of
teratogenicity. CADUET should be administered to women of childbearing age only
when such patients are highly unlikely to conceive and have been informed of
the potential hazard. If the patient becomes pregnant while taking this drug,
therapy should be discontinued immediately and the patient apprised of the
potential hazard to the fetus [seeSpecific Populations].

Nursing Mothers

It is not known whether atorvastatin or amlodipine are
excreted into human milk; however, a small amount of another statin does pass
into breast milk. Because statins have the potential for serious adverse
reactions in nursing infants, women taking CADUET should not breastfeed their
infants [seeSpecific Populations].

Last reviewed on RxList: 6/5/2014
This monograph has been modified to include the generic and brand name in many instances.